Seventy percent of pregnant women are bothered by nausea and vomiting during pregnancy (“NVP”), commonly known as “morning sickness”, though the pattern is often more than just in the morning. The nausea and vomiting can range from mild nausea to “hyperemesis gravid arum” in which the patient is unable to hold down food. Until, recent years there were no FDA-approved drugs to treat NVP.
So, doctors prescribed a host of medications for “off-label” use — drugs prescribed for something other than what the drug was designed to treat. Indeed, currently 97% of prescriptions for pregnancy-related nausea and vomiting are for medications that are not designed or labeled for use in pregnancy. One of those drugs is Zofran.
Zofran is a powerful drug developed for use in chemotherapy-induced nausea and vomiting, which is often prescribed for pregnancy-induced nausea and vomiting. Accordingly, there are are serious questions regarding maternal and fetal safety associated with these off-label prescriptions.
In a large study by the Slone Epidemiology Center and the Center for Disease Control and Prevention in Atlanta, a two-fold increase in cleft- palate deformities was associated with first trimester use of Zofran or Ondansetron.
Women who were prescribed Zofran or Ondansetron during the first trimester, to treat NVP, had a twice the number of cleft-palate abnormalities as those who had not taken the medication. This is important as physicians have been prescribing medications without specific indications for their use and the consequences have been dramatic and affected the lives of many.
Cleft lip and palate deformity is a craniofacial anomaly in which the soft and or hard palate fails to form completely. The lip also fails to form normally, sometimes fusing with the soft tissues of the nose. There are multiple variants of the congenital abnormality.
Clefts of the lip and palate may result in hearing, speech and swallowing disorders. These children require follow-up from infancy through adulthood.
The repair of this birth defect requires multiple staged surgical procedures, by a multidisciplinary team of surgeons, pediatric dentists, speech pathologists and psychologists. The average cost of surgical correction alone is conservatively estimated at $100,000 per child. Soft palate closure must occur before 18 months of age. Hard palate closure should occur between 3 and 5 years of age. The soft tissue surgery of lip and nose must take into account growth and development with attention to aesthetics and symmetry of the face. Even after surgical repairs have taken place, there are dental issues and often orthodontia or prosthetic dentistry is required. Hearing loss is also very common due to problems with the Eustachian tube. Some 50% of children with cleft-palate deformity will develop hearing loss due to repeat ear infections. This can of course impact speech in a viscous cycle, during the critical period in speech development.
Emotional and Psychological Toll
These birth defects affect the face, the very first impression we are all judged upon. Secondly, they affect the child’s ability to swallow and speak and hear. This takes an unimaginable toll on both child and parent. And because of the staged nature of the correction, the defect just doesn’t simply go away. We are talking about years of staged surgeries. Thousands of hours relegated to speech therapy. The defect often affects the eruption of teeth, and requires dental prosthetics or orthodontia in adolescence. Psychologists are an important part of the multidisciplinary team. Children can be cruel. Children suffering through these birth defects may be teased and suffer psychological trauma. So while conservative estimates indicate that costs of reconstruction for a child with a cleft-palate deformity is conservatively estimated at 100,000 per child. It is certainly arguable that estimate does not begin to touch the actual human cost of this birth defect.
If your child has suffered a birth defect or injury you suspect was caused by the negligence of a medical professional or pharmaceutical defect, call Passen & Powell at 312-527-4500 for a free consultation.